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FDA 510(k)

ETHEREA

K-Number: K112505 · 2012-04-06

ApplicantRegulatory Insight, Inc.
Decision Date2012-04-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ETHEREA is the device name listed in this FDA 510(k) record. The listed applicant is Regulatory Insight, Inc.. It received FDA 510(k) clearance on 2012-04-06 under 510(k) number K112505. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHEREA?

ETHEREA is a medical device that received FDA 510(k) clearance on 2012-04-06. The listed applicant is Regulatory Insight, Inc.. The 510(k) number is K112505.

When did ETHEREA receive FDA 510(k) clearance?

ETHEREA received FDA 510(k) clearance on 2012-04-06, under 510(k) number K112505.

Who is the listed applicant for ETHEREA?

The FDA 510(k) record lists Regulatory Insight, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETHEREA?

The FDA product code for ETHEREA is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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